a multicenter, double-blind, parallel, non-inferiority, phase iii study

Conditions: Influenza

Summary: a multicenter, randomized, double-blind, active-controlled, parallel, non-inferiority, phase iii study.

a multicenter, randomized, double-blind, active-controlled, parallel, non-inferiority, phase iii study to investigate the efficacy (immunogenicity) and safety of gc3106 (quadrivalent cell-culture based influenza vaccine) after intramuscular administration in healthy subjects.

Eligibility criteria:
inclusion criteria: * given written informed consent * healthy korean adults (age: between over 19) * women of childbearing age with negative urine hcg in screening visit exclusion criteria: * subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary) * subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug) * subjects with impaired immune functions that include immune deficiency diseases * subjects with a history of guillain-barre syndrome * hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant * subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration * subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure * subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity * subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or formaldehyed, gentamicin and sodium deoxychloate * subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product * subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period * subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration * subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days) * subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period * pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, iud, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy) subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study

Keywords: cciv quadrivalent cell-culture based influenza vaccine influenza vaccine vaccination